Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin
NCT ID: NCT02370121
Last Updated: 2019-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2013-02-28
2015-01-31
Brief Summary
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Detailed Description
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Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo
Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Gymnema Sylvestre
600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre
Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Interventions
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Placebo
Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Gymnema Sylvestre
Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index: 25-34.99 kg/m2
* Body weight without variations above or under 5% during the three months prior to the study
* Diagnostic of metabolic syndrome according to the modified International Diabetes Federation definition: Central obesity (defined as waist circumference ≥ 80 cm in women and ≥ 90 cm in men)
Plus any two of the following four factors:
* Triglycerides: 150-499 mg/dL.
* High density lipoprotein: Woman \< 50 mg/dL, man \< 40 mg/dL.
* Blood pressure systolic:130-139 mmHg and/or Blood pressure diastolic: 85-89 mmHg
* Fasting glucose: 100-125 mg/dL
Exclusion Criteria
* Previous pharmacological treatment for components of metabolic syndrome
* Mental or physical illness interfering with the study
* Thyroid or cardiovascular disease
* Pregnant or suspected pregnant women
* Woman breastfeeding
* Index of body mass: ≥ 35 kg/m2
* Treatments known to affect metabolism of glucose, fats and affecting arterial tension
* Patients with hepatic or renal diseases background
* Patients diagnosed with kidneys disease
* Calcined magnesium intolerance
* Gymnema Sylvestre intolerance
30 Years
60 Years
ALL
No
Sponsors
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University of Guadalajara
OTHER
Responsible Party
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Esperanza Martínez-Abundis
Researcher Professor
Principal Investigators
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Esperanza Martínez, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Experimental and Clinical Therapeutics
References
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Lann D, LeRoith D. Insulin resistance as the underlying cause for the metabolic syndrome. Med Clin North Am. 2007 Nov;91(6):1063-77, viii. doi: 10.1016/j.mcna.2007.06.012.
Abdul-Ghani MA, Matsuda M, Balas B, DeFronzo RA. Muscle and liver insulin resistance indexes derived from the oral glucose tolerance test. Diabetes Care. 2007 Jan;30(1):89-94. doi: 10.2337/dc06-1519.
Sandeep S, Gokulakrishnan K, Velmurugan K, Deepa M, Mohan V. Visceral & subcutaneous abdominal fat in relation to insulin resistance & metabolic syndrome in non-diabetic south Indians. Indian J Med Res. 2010 May;131:629-35.
Al-Romaiyan A, Liu B, Asare-Anane H, Maity CR, Chatterjee SK, Koley N, Biswas T, Chatterji AK, Huang GC, Amiel SA, Persaud SJ, Jones PM. A novel Gymnema sylvestre extract stimulates insulin secretion from human islets in vivo and in vitro. Phytother Res. 2010 Sep;24(9):1370-6. doi: 10.1002/ptr.3125.
Shigematsu N, Asano R, Shimosaka M, Okazaki M. Effect of administration with the extract of Gymnema sylvestre R. Br leaves on lipid metabolism in rats. Biol Pharm Bull. 2001 Jun;24(6):713-7. doi: 10.1248/bpb.24.713.
Baskaran K, Kizar Ahamath B, Radha Shanmugasundaram K, Shanmugasundaram ER. Antidiabetic effect of a leaf extract from Gymnema sylvestre in non-insulin-dependent diabetes mellitus patients. J Ethnopharmacol. 1990 Oct;30(3):295-300. doi: 10.1016/0378-8741(90)90108-6.
Porchezhian E, Dobriyal RM. An overview on the advances of Gymnema sylvestre: chemistry, pharmacology and patents. Pharmazie. 2003 Jan;58(1):5-12.
Koshu K, Hirota S, Sonobe M, Takahashi S, Takaku A, Saito T, Ushijima T. [Continuous recording of cerebral blood flow by means of thermal diffusion method using Peltier stack]. Neurol Med Chir (Tokyo). 1987 Aug;27(8):724-8. doi: 10.2176/nmc.27.724. No abstract available. Japanese.
Bhansali S, Shafiq N, Pandhi P, Singh AP, Singh I, Singh PK, Sharma S, Malhotra S. Effect of a deacyl gymnemic acid on glucose homeostasis & metabolic parameters in a rat model of metabolic syndrome. Indian J Med Res. 2013 Jun;137(6):1174-9.
Tiwari P, Mishra BN, Sangwan NS. Phytochemical and pharmacological properties of Gymnema sylvestre: an important medicinal plant. Biomed Res Int. 2014;2014:830285. doi: 10.1155/2014/830285. Epub 2014 Jan 6.
Kumar V, Bhandari U, Tripathi CD, Khanna G. Protective Effect of Gymnema sylvestre Ethanol Extract on High Fat Diet-induced Obese Diabetic Wistar Rats. Indian J Pharm Sci. 2014 Jul;76(4):315-22.
Astell KJ, Mathai ML, Su XQ. Plant extracts with appetite suppressing properties for body weight control: a systematic review of double blind randomized controlled clinical trials. Complement Ther Med. 2013 Aug;21(4):407-16. doi: 10.1016/j.ctim.2013.05.007. Epub 2013 Jun 24.
Al-Romaiyan A, King AJ, Persaud SJ, Jones PM. A novel extract of Gymnema sylvestre improves glucose tolerance in vivo and stimulates insulin secretion and synthesis in vitro. Phytother Res. 2013 Jul;27(7):1006-11. doi: 10.1002/ptr.4815. Epub 2012 Aug 21.
Ogawa Y, Sekita K, Umemura T, Saito M, Ono A, Kawasaki Y, Uchida O, Matsushima Y, Inoue T, Kanno J. [Gymnema sylvestre leaf extract: a 52-week dietary toxicity study in Wistar rats]. Shokuhin Eiseigaku Zasshi. 2004 Feb;45(1):8-18. doi: 10.3358/shokueishi.45.8. Japanese.
Okabayashi Y, Tani S, Fujisawa T, Koide M, Hasegawa H, Nakamura T, Fujii M, Otsuki M. Effect of Gymnema sylvestre, R.Br. on glucose homeostasis in rats. Diabetes Res Clin Pract. 1990 May-Jun;9(2):143-8. doi: 10.1016/0168-8227(90)90106-4.
Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.
Tai MM. A mathematical model for the determination of total area under glucose tolerance and other metabolic curves. Diabetes Care. 1994 Feb;17(2):152-4. doi: 10.2337/diacare.17.2.152.
Renga B, Festa C, De Marino S, Di Micco S, D'Auria MV, Bifulco G, Fiorucci S, Zampella A. Molecular decodification of gymnemic acids from Gymnema sylvestre. Discovery of a new class of liver X receptor antagonists. Steroids. 2015 Apr;96:121-31. doi: 10.1016/j.steroids.2015.01.024. Epub 2015 Feb 7.
Stumvoll M, Mitrakou A, Pimenta W, Jenssen T, Yki-Jarvinen H, Van Haeften T, Renn W, Gerich J. Use of the oral glucose tolerance test to assess insulin release and insulin sensitivity. Diabetes Care. 2000 Mar;23(3):295-301. doi: 10.2337/diacare.23.3.295.
Izutani Y, Murai T, Imoto T, Ohnishi M, Oda M, Ishijima S. Gymnemic acids inhibit rabbit glyceraldehyde-3-phosphate dehydrogenase and induce a smearing of its electrophoretic band and dephosphorylation. FEBS Lett. 2005 Aug 15;579(20):4333-6. doi: 10.1016/j.febslet.2005.06.070.
Wang Y, Dawid C, Kottra G, Daniel H, Hofmann T. Gymnemic acids inhibit sodium-dependent glucose transporter 1. J Agric Food Chem. 2014 Jun 25;62(25):5925-31. doi: 10.1021/jf501766u. Epub 2014 Jun 10.
Other Identifiers
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CT-271281-YZ
Identifier Type: -
Identifier Source: org_study_id
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